About this trial
This prospective, observational study evaluates whether serum bicarbonate HCO3 levels can predict enteral nutrition intolerance (EFI) in adult ICU patients.Objective: To determine if lower HCO3 levels correlate with the development of EFI.Design: A 12-month study involving 70 participants at Sultangazi Haseki Training and Research Hospital.Methodology: Patients starting enteral nutrition within 48 hours of admission will be monitored for 72 hours. Daily HCo3 pH, and lactate levels will be recorded from routine morning blood draws.Hypothesis: Lower bicarbonate levels are an independent predictor of EFI development in critically ill patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 and older.
Patients started on enteral nutrition (EN) within the first 48 hours of their intensive care unit admission.
Patients predicted to remain in the intensive care unit for at least 72 hours.
Patients (or their legal representatives) who have provided consent to participate in the study.
Disqualifiers
Patients under the age of 18.Individuals who are currently pregnant or breastfeeding.
Patients with gastrointestinal (GI) perforation, active GI bleeding, or mechanical bowel obstruction.
Patients who have undergone major abdominal surgery (e.g., esophagectomy, gastrectomy) within the last month.
Patients receiving total parenteral nutrition (TPN) or those who are only fed orally.
Trial population
The study population consists of adult patients aged 18 and older who are admitted to the intensive care unit (ICU). This group specifically includes those who begin enteral nutrition (EN) within the first 48 hours of their ICU admission and are expected to remain in the unit for at least 72 hours. The target sample size is 70 participants, factoring in potential drop-outs to maintain statistical power. Certain clinical conditions are excluded to ensure data consistency, such as pregnancy, 18 years of age or younger, active gastrointestinal bleeding or perforation, and recent major abdominal surgery. Additionally, patients requiring specialized enteral formulas or those with advanced organ failure (e.g., Child-Pugh C liver failure or dialysis-dependent kidney failure) are not included in the study population.
Trial design
Cohort
Prospective
Treatments tested in this trial
Enteral Nutrition Intolerance (EFI)
Other interventionThe study investigates the development of EFI, characterized by symptoms like increased gastric residual volume, vomiting, and abdominal distension.
Treatment groups
Trial outcomes
Primary outcomes
The relationship between serum bicarbonate levels and enteral nutrition intolerance (EFI).
Evaluation of daily serum bicarbonate ($HCO\_3\^-$) levels as a predictor for the development of enteral nutrition intolerance in adult intensive care patients. This includes determining the most appropriate cut-off values, sensitivity, and specificity through ROC curve analysis.
Sponsors and contacts
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